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Depression research study

What is the primary objective of this study?

OBJECTIVES:
To evaluate the comparative efficacy and security of Continuation Electroconvulsive Therapy
associated with pharmacotherapy versus pharmacotherapy alone in the prevention of depressive
relapse.
METHODS:
Demographic and clinical variables will be collected and side effects scales and
neurocognitive battery will be performed. Variables of efficacy: relapse percentage in both
groups in one year (primary variable); time without relapse. Main variable of security:
occurrence of side effects and neurocognitive performance.
DESIGN: Randomized controlled clinical trial.
SAMPLE:
104 outpatients diagnosed with unipolar depression (DSM-IV-R criteria) who had remitted with
a course of bilateral ECT. They will be randomized to two groups of treatment.
SETTING: Psychiatry Department at Bellvitge University Hospital.
ANALYSIS: Descriptive analysis of clinical variables; survive analysis and Cox model of
regression.

Who is eligible to participate?

Inclusion Criteria:
- MDD diagnosis by DSM IV-TR.
- ECT requirement during acute episode. Therapeutic indication will be based on clinical
criteria, following APA guidelines. During the acute episode, patients will be
controlled by the usual clinical care team.
- Complete clinical remission (HDRS < or = 7 across two weeks).
- Appropriate intellectual level that allows adequate communication.
- Women of childbearing potential must use contraceptive methods.
- Signed Consent form.
- Other axis I or II diagnosis by DSM-IV-TR, except for nicotine dependence.
- To be in maintenance ECT program.
- To receive ECT during the previous three months of the acute episode.
- Pregnancy or breastfeeding.
Exclusion Criteria:
- Other axis I or II diagnosis by DSM-IV-TR, except for nicotine dependence.
- To be in maintenance ECT program.
- To receive ECT during the previous three months of the acute episode.
- Pregnancy or breastfeeding.

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:C-ECTC-ECT will be administered through a Thrymatron System IV device (Somatics, LLC, ISO 13485:2003). Electrode placement will be bilateral and energy administered during consolidation treatment will be same used in the acute episode. C-ECT will be given weekly for the first month, fortnightly for the following two months and monthly during the next 6 months. A total of 14 C-ECT sessions will be given over 9 months of treatment.
Pharmacotherapy will remain unchanged since the acute episode to the end of the study. Drugs will be obtained as usually from the National Health System and will be prescribed according to data sheet and it will have a duration of 15 months.

Drug:PHARMACOTHERAPYPharmacotherapy will remain unchanged since the acute episode to the end of the study. Psychotropics will be obtained as usually from the National Health System and will be prescribed according to data sheet and will have a 15 month duration.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

C-ECT and PharmacotherapyConsolidation treatment with ECT will be considered finished after 9 months of being started, at which time patients will stay only on the pharmacological treatment they already had. The study will be completed within 15 months of patient inclusion (six months after the end of C-ECT). Patient assessment and follow-up will be conducted by participant researchers. Blind rater will conduct clinical and adverse effects ratings. A neuropsychologist will conduct neuropsychological assessments.

PharmacotherapyPharmacotherapy will remain unchanged since the acute episode to the end of the study. Psychotropics will be obtained as usually from the National Health System and will be prescribed according to data sheet.

Study Status

Terminated

Start Date: July 2009

Completed Date: July 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Hamilton Depression Rating Scale 21 items (HDRS-21)

Secondary Outcome: Mini-Mental State Examination (MMSE 35)

Study sponsors, principal investigator, and references

Principal Investigator: Mikel Urretavizcaya Sarachaga, MD, PhD

Lead Sponsor: Hospital Universitari de Bellvitge

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01305707

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